Navigating the introduction of anti-amyloid therapy in Europe: a position statement by individual members of the EADC
Jazyk angličtina Země Velká Británie, Anglie Médium electronic
Typ dokumentu časopisecké články, přehledy
PubMed
40413561
PubMed Central
PMC12102950
DOI
10.1186/s13195-025-01766-y
PII: 10.1186/s13195-025-01766-y
Knihovny.cz E-zdroje
- Klíčová slova
- Alzheimer´s disease, Anti-amyloid antibodies, Mild cognitive impairment, Recommendations,
- MeSH
- Alzheimerova nemoc * farmakoterapie terapie MeSH
- amyloidní beta-protein * imunologie MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- amyloidní beta-protein * MeSH
INTRODUCTION: Anti-amyloid antibodies for the treatment of Alzheimer´s disease (AD) are currently being evaluated for approval and reimbursement in Europe. An approval brings opportunities, but also challenges to health care systems across Europe. The objective of this position paper is to provide guidance from experts in the field in terms of navigating implementation. METHODS: Members of the European Alzheimer's Disease Consortium and a representative of Alzheimer Europe convened to formulate recommendations covering key areas related to the possible implementation of anti-amyloid antibodies in AD through online discussions and 2 rounds of online voting with an 80% threshold for a position to be accepted. RESULTS: In total, 24 recommendations were developed covering the research landscape and priorities within research in AD following a possible approval, potential impact on health care systems and diagnostic pathways, and communication to patients about anti-amyloid antibodies. Anti-amyloid antibodies are regarded as a substantial innovation with an important clinical impact. In addition, however, new compounds with other mechanisms of action and/or route of administration are also needed. Approval of new treatments will require changes to existing patient pathways and real-world data needs to be generated. CONCLUSION: Comprehensive guidance is provided on the potential implementation of anti-amyloid antibody therapies in Europe following possible approval. Emphasis is placed on the necessity of regularly updating recommendations as new evidence emerges in the coming years.
Ace Alzheimer Center Barcelona Universitat Internacional de Catalunya Barcelona Spain
Aging and Inflammation Theme Karolinska University Hospital Stockholm Sweden
Alzheimer Europe Luxembourg Luxembourg
Carol Davila University of Medicine and Pharmacy Bucharest Romania
Clinical Division of Neurogeriatrics Department of Neurology Medical University Graz Graz Austria
Dementia Research Centre UCL Queen Square Institute of Neurology UCL London UK
Department of Biomedical Sciences University of Antwerp Antwerp Belgium
Department of Neurology and Bru BRAIN NEUR Research Group Center for Neurosciences Brussels Belgium
Department of Psychiatry Medical Faculty University of Cologne Cologne Germany
Faculty Geneva College of Longevity Science Geneva Switzerland
Frontlab Paris Brain Institute AP HP Pitié Salpêtrière Hospital Paris France
German Center for Neurodegenerative Diseases Bonn Germany
Networking Research Center On Neurodegenerative Diseases Instituto de Salud Carlos 3 Madrid Spain
Toulouse Clinical Research Center Toulouse University Hospital Toulouse France
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Hardy JA, Higgins GA. Alzheimer’s disease: the amyloid cascade hypothesis. Science [Internet]. 1992Apr 10;256(5054):184–5. PubMed
Cummings J, Zhou Y, Lee G, Zhong K, Fonseca J, Cheng F. Alzheimer’s disease drug development pipeline: 2023. Alzheimer’s Dement Transl Res Clin Interv. 2023;9(2). PubMed PMC
Panza F, Lozupone M, Logroscino G, Imbimbo BP. A critical appraisal of amyloid-β-targeting therapies for Alzheimer disease. Nat Rev Neurol [Internet]. 2019Feb;15(2):73–88. PubMed
Budd Haeberlein S, Aisen PS, Barkhof F, Chalkias S, Chen T, Cohen S, et al. Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease. J Prev Alzheimer’s Dis. 2022;9(2):197–210. PubMed
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, et al. Lecanemab in Early Alzheimer’s Disease. N Engl J Med. 2023Jan 5;388(1):9–21. PubMed
Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks JD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512–27. PubMed PMC
Jones RW, Mackell J, Berthet K, Knox S. Assessing attitudes and behaviours surrounding Alzheimer’s disease in Europe: key findings of the Important Perspectives on Alzheimer’s Care and Treatment (IMPACT) survey. J Nutr Health Aging. 2010Aug;14(7):525–30. PubMed
Jönsson L, Wimo A, Handels R, Johansson G, Boada M, Engelborghs S, et al. Viewpoint The affordability of lecanemab , an amyloid-targeting therapy for Alzheimer ’ s disease : an EADC-EC viewpoint. 2023;29:1–7. PubMed PMC
Dubois B, Feldman HH, Jacova C, Hampel H, Molinuevo JL, Blennow K, et al. Advancing research diagnostic criteria for Alzheimer’s disease: The IWG-2 criteria. Lancet Neurol. 2014;13(6):614–29. PubMed
Dubois B, Villain N, Schneider L, Fox N, Campbell N, Galasko D, et al. Alzheimer Disease as a Clinical-Biological Construct—An International Working Group Recommendation. JAMA Neurol. 2024 Nov 1; PubMed PMC
Jack CR, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, et al. NIA-AA Research Framework: Toward a biological definition of Alzheimer’s disease. Alzheimer’s Dement. 2018;14(4):535–62. PubMed PMC
World Alzheimer Report 2021.
Karikari TK, Pascoal TA, Ashton NJ, Janelidze S, Benedet AL, Rodriguez JL, et al. Blood phosphorylated tau 181 as a biomarker for Alzheimer’s disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. Lancet Neurol. 2020;19(5):422–33. PubMed
Palmqvist S, Tideman P, Cullen N, Zetterberg H, Blennow K, Dage JL, et al. Prediction of future Alzheimer’s disease dementia using plasma phospho-tau combined with other accessible measures. Nat Med. 2021;27(6):1034–42. PubMed
Barthélemy NR, Salvadó G, Schindler SE, He Y, Janelidze S, Collij LE, et al. Highly accurate blood test for Alzheimer’s disease is similar or superior to clinical cerebrospinal fluid tests. Nat Med. 2024Apr;30(4):1085–95. PubMed PMC
Hansson O, Edelmayer RM, Boxer AL, Carrillo MC, Mielke MM, Rabinovici GD, et al. The Alzheimer’s Association appropriate use recommendations for blood biomarkers in Alzheimer’s disease. Alzheimer’s Dement. 2022;18(12):2669–86. PubMed PMC
Frederiksen KS, Cooper C, Frisoni GB, Frölich L, Georges J, Kramberger MG, et al. A European Academy of Neurology guideline on medical management issues in dementia. Eur J Neurol. 2020;27(10):1805–20. PubMed PMC
Walsh S, Merrick R, Richard E, Nurock S, Brayne C. Lecanemab for Alzheimer’s disease. BMJ. 2022Dec;19(372): o3010. PubMed
Kvello-Alme M, Bråthen G, White LR, Sando SB. Time to diagnosis in young onset alzheimer’s disease: A population-based study from central Norway. J Alzheimer’s Dis. 2021;82(3):965–74. PubMed PMC
Wahlberg K, Winblad B, Cole A, Herring WL, Ramsberg J, Torontali I, et al. People get ready! A new generation of Alzheimer’s therapies may require new ways to deliver and pay for healthcare. J Intern Med. 2023;1–11. PubMed
Langhorne P. The Stroke Unit Story: Where Have We Been and Where Are We Going? Cerebrovasc Dis. 2021;50(6):636–43. PubMed
Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, et al. Donanemab in Early Alzheimer’s Disease. N Engl J Med. 2021May 6;384(18):1691–704. PubMed
Filippi M, Cecchetti G, Spinelli EG, Vezzulli P, Falini A, Agosta F. Amyloid-Related Imaging Abnormalities and β-Amyloid-Targeting Antibodies: A Systematic Review. JAMA Neurol. 2022;79(3):291–304. PubMed
Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimer’s Res Ther. 2021;13(1):1–14. PubMed PMC
Shcherbinin S, Evans CD, Lu M, Andersen SW, Pontecorvo MJ, Willis BA, et al. Association of Amyloid Reduction after Donanemab Treatment with Tau Pathology and Clinical Outcomes: The TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022;79(10):1015–24. PubMed PMC
Pontecorvo MJ, Lu M, Burnham SC, Schade AE, Dage JL, Shcherbinin S, et al. Association of Donanemab Treatment With Exploratory Plasma Biomarkers in Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022;79(12):1250–9. PubMed PMC
Boxer AL, Sperling R. Accelerating Alzheimer’s therapeutic development: The past and future of clinical trials. Cell. 2023Oct;186(22):4757–72. PubMed PMC
Collij LE, Bollack A, La Joie R, Shekari M, Bullich S, Roé-Vellvé N, et al. Centiloid recommendations for clinical context-of-use from the AMYPAD consortium. Alzheimer’s Dement. 2024Dec 20;20(12):9037–48. PubMed PMC
Karran E, Mercken M, De SB. The amyloid cascade hypothesis for Alzheimer’s disease: an appraisal for the development of therapeutics. Nat Rev Drug Discov. 2011Sep 19;10(9):698–712. PubMed
Jucker M, Walker LC. Alzheimer’s disease: From immunotherapy to immunoprevention. Cell. 2023Sep;186(20):4260–70. PubMed PMC
Cummings J, Aisen P, Lemere C, Atri A, Sabbagh M, Salloway S. Aducanumab produced a clinically meaningful benefit in association with amyloid lowering. Alzheimer’s Res Ther. 2021;13(1):10–2. PubMed PMC
Rabinovici GD, La Joie R. Amyloid-Targeting Monoclonal Antibodies for Alzheimer Disease. JAMA. 2023;330(6):507–9. PubMed
Walsh S, Merrick R, Milne R, Brayne C. Aducanumab for Alzheimer’s disease? BMJ. 2021;374(August):34226181. PubMed PMC
Day GS, Scarmeas N, Dubinsky R, Coerver K, Mostacero A, West B, et al. Aducanumab Use in Symptomatic Alzheimer Disease Evidence in Focus. Vol. 98, Neurology. 2022. 619–631 p. PubMed PMC
Jessen F, Kramberger MG, Angioni D, Aarsland D, Balasa M, Bennys K, et al. Progress in the Treatment of Alzheimer’s Disease Is Needed - Position Statement of European Alzheimer’s Disease Consortium (EADC) Investigators. J Prev Alzheimer’s Dis. 2024;11(5):1212–8. PubMed PMC
Krysinska K, Sachdev PS, Breitner J, Kivipelto M, Kukull W, Brodaty H. Dementia registries around the globe and their applications: A systematic review. Alzheimer’s Dement. 2017;13(9):1031–47. PubMed PMC
Naemi R, Shahmoradi L. Global Experience of Diabetes Registries: A Systematic Review. 2020;441–55. PubMed
Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, et al. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients with Early Alzheimer Disease. JAMA Neurol. 2022;79(1):13–21. PubMed PMC
Sperling R, Salloway S, Brooks DJ, Tampieri D, Barakos J, Fox NC, et al. Amyloid-related imaging abnormalities in patients with Alzheimer’s disease treated with bapineuzumab: A retrospective analysis. Lancet Neurol. 2012;11(3):241–9. PubMed PMC
Jeong SY, Suh CH, Shim WH, Lim JS, Lee JH, Kim SJ. Incidence of Amyloid-Related Imaging Abnormalities in Patients with Alzheimer Disease Treated with Anti-β-Amyloid Immunotherapy: A Meta-analysis. Neurology. 2022;99(19):E2092–101. PubMed
Solopova E, Romero-Fernandez W, Harmsen H, Ventura-Antunes L, Wang E, Shostak A, et al. Fatal Iatrogenic Cerebral Amyloid-Related Encephalitis in a patient treated with lecanemab for Alzheimer’s disease: neuroimaging and neuropathology. medRxiv. 2023;2023.04.26.23289061.